Registered Tanzania · TMDA

Udihep Forte

Ursodeoxycholic Acid 300 mg

TZ 15 H 0346 Tablets 300 mg

What it does

Ursodeoxycholic acid is a medicine that helps improve liver function and can assist with certain liver diseases.

Commonly used for: liver disease, biliary cirrhosis, gallstones

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Registration & product details

Registration no.
TZ 15 H 0346
Registration date
2025-11-10
Expiry date
2030-11-09
Status
Registered/Compliant
Active ingredient
Ursodeoxycholic Acid 300 mg
Dosage form
Tablets
Strength
300 mg
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Win-medicare
Applicant / LTR
Win-Medicare Pvt. Ltd
Country of origin
INDIA
Manufacturer location
158/177, National High School Road, Vishweshwarapura, Basavanagudi, Bengaluru, Karnataka 560004, India

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:51:49 · updated 2026-09-17 03:00:44

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About this medicine

Ursodeoxycholic acid is a medicine that helps improve liver function and can assist with certain liver diseases.

What it treats

  • liver disease
  • biliary cirrhosis
  • gallstones

How it works

It works by helping to dissolve cholesterol in the bile and promoting better liver health.

Who it's for

This medicine is for adults with specific liver problems or gallstones.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: ursodeoxycholic

Ursodeoxycholic acid is a bile acid that naturally occurs in the body. It is primarily used to dissolve cholesterol gallstones and to treat certain liver diseases, such as primary biliary cholangitis. It works by reducing cholesterol levels in bile, promoting bile flow, and enhancing the solubility of bile salts.

Indications

  • Dissolution of cholesterol gallstones
  • Primary biliary cholangitis
  • Cholestatic liver disease

Dosage

Children: Refer to BNF for Children for appropriate paediatric dosing information.

Adults: Refer to BNF for specific dosing guidelines, as doses may vary based on the condition being treated.

Mechanism of action

Ursodeoxycholic acid works by decreasing the hepatic synthesis and secretion of cholesterol, thereby reducing cholesterol saturation in bile. It promotes the secretion of bile acids and enhances the solubilization of cholesterol in bile, facilitating the dissolution of cholesterol gallstones and improving liver function in cholestatic liver diseases.

Pharmacodynamics

The pharmacodynamic properties of ursodeoxycholic acid involve its ability to reduce liver inflammation, lower serum liver enzymes, and improve liver histology in patients with cholestatic liver diseases. Its effects on cholesterol metabolism help in the dissolution of gallstones and improve bile flow.

Pharmacokinetics

Ursodeoxycholic acid is well absorbed from the gastrointestinal tract. It undergoes enterohepatic recirculation, with a half-life of approximately 3 to 5 hours. It is metabolized in the liver and excreted mainly in the bile. The bioavailability of ursodeoxycholic acid is influenced by food intake, with absorption being increased when taken with meals.

Interactions

  • fibrates+ursodeoxycholic acid: Severe (decreases efficacy)
  • ursodeoxycholic acid+ciclosporin: Moderate (affects concentration)

Pregnancy

Ursodeoxycholic acid should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Ursodeoxycholic acid is excreted in breast milk. Caution should be exercised when administered to a nursing woman.

Storage

Store at room temperature, away from moisture and heat.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.